Phase 3
N=3,902
Trial to Evaluate the Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-naïve Adults
Pneumococcal Disease
Bottom Line
View on ClinicalTrials.gov: NCT03760146 ↗Enrolled (actual)
3,902
Serious AEs
1.8%
Results posted
Dec 2020
Primary outcome: Primary: Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts — 7.3; 6.2; 8.2; 5.4 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 20vPnC (Biological); 13vPnC (Biological); PPSV23 (Biological); Saline (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts |
7.3; 6.2; 8.2; 5.4; 9.0; 9.8 | — |
| PRIMARY Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts |
0.9; 0.8; 1.5; 0.9; 1.2; 1.8 | — |
| PRIMARY Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination in All Cohorts |
9.8; 11.1; 10.2; 8.1; 15.2; 11.6 | — |
| PRIMARY Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination in All Cohorts |
2.4; 1.9; 0.3; 0.9; 0.6; 0.9 | — |
| PRIMARY Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination in All Cohorts |
2.3; 2.3; 1.5; 0.9; 1.5; 1.8 | — |
| PRIMARY Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population |
123.4; 153.8; 40.7; 47.8; 508.7; 626.9 | — |
| PRIMARY Pneumococcal OPA GMTs for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population (E7-AIP) |
465.6; 848.1; 2007.6; 1079.9; 4426.8; 2534.9 | — |
| SECONDARY Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population |
135.9; 131.8; 43.3; 40.9; 633.3; 577.9 | — |
| SECONDARY Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population |
162.6; 132.0; 42.1; 42.0; 1966.7; 594.5 | — |
| SECONDARY Pneumococcal OPA Geometric Mean Fold Rises (GMFRs) for the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population |
12.6; 15.4; 4.8; 5.8; 31.2; 39.3 | — |
| SECONDARY Pneumococcal OPA GMFRs for the Additional 7 Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population |
22.1; 40.4; 18.5; 10.1; 9.3; 6.0 | — |
| SECONDARY Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population |
14.4; 18.6; 5.1; 4.8; 43.4; 131.8 | — |
| SECONDARY Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers to the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population |
72.1; 74.8; 56.1; 61.7; 75.5; 79.6 | — |
| SECONDARY Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 7 Additional Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1(20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2(PPSV23) in Cohort 1:E7-AIP |
77.8; 86.8; 75.5; 65.6; 59.2; 51.9 | — |
| SECONDARY Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population |
74.9; 86.0; 59.0; 56.7; 84.2; 91.4 | — |
| SECONDARY Percentage of Participants With Pneumococcal OPA Titers >= Lower Limit of Quantitation (LLOQ) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population |
85.0; 87.9; 84.2; 87.0; 91.1; 92.1 | — |
| SECONDARY Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population |
92.9; 96.6; 95.6; 88.9; 97.7; 95.4 | — |
| SECONDARY Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population |
87.2; 92.1; 87.4; 89.9; 94.0; 98.1 | — |
Summary
A Phase 3, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults
Eligibility Criteria
Inclusion Criteria
- Male or female adults >/= 18 years of age (from the 18th birthday) at enrollment and older.
- Adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease, defined as disease not requiring significant change in therapy in the previous 6 weeks or hospitalization for worsening disease within 12 weeks before receipt of investigational product.
- Negative urine pregnancy test at Visit1 for all subjects who are of childbearing potential.
Exclusion Criteria
- Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
- History of microbiologically proven invasive disease caused by S pneumoniae.
- Serious chronic disorder including metastatic malignancy, severe chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the subject from participating in the study.
- Pregnant female subjects or breastfeeding female subjects.
Data sourced from ClinicalTrials.gov (NCT03760146). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.